Altimmune宣布在奥地利维也纳举行的国际肝病大会上展示HepTcell

StephenW

Altimmune Announces Presentation of HepTcell Phase 1 Results at The International Liver Congress™ in Vienna, Austria

GAITHERSBURG, Md., Jan. 29, 2019 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced results of its recently completed HepTcell Phase 1 clinical trial will be presented on April 12, 2019 at The International Liver Congress sponsored by The European Association for the Study of the Liver (EASL) being held in Vienna, Austria April 10-14, 2019.

As previously announced, this study met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. These results will be presented by Mark Thursz, MB BS, MD, FRCP, Professor of Hepatology at Imperial College, London as an oral presentation in the session entitled, Hepatitis B – Drug Development.

“I am very pleased to present these exciting HepTcell data at EASL’s Liver Congress,” said Professor Thursz, Chief Investigator for the HepTcell Phase 1 study. “HepTcell’s impact on HBV specific cellular immune responses is very encouraging and the safety profile is excellent.”

Hepatitis B virus (HBV) has infected more than 2 billion people worldwide. The majority of adults infected with HBV achieve spontaneous clearance via HBV-specific CD4+ and CD8+ T cells; however, more than 257 million people worldwide, of which 2 million patients are in the United States, remain chronically infected. HBV remains a leading cause of death globally due to complications such as cirrhosis, liver failure and hepatocellular carcinoma. Patients with chronic infection have profound defects in magnitude and quality of anti-HBV T-cell responses and breaking this immune tolerance is a key goal for all novel HBV treatment strategies.

Altimmune’s HepTcell is a specific HBV immunotherapeutic designed to drive CD4+ and CD8+ T-cell responses against all HBV genotypes in patients of all ethnic backgrounds. HepTcell focuses the immune system on discrete highly conserved regions of the HBV proteome. We believe our approach allows HepTcell to activate less tolerized T cells resulting in greater activity and decreased probability of immune escape due to viral mutation. HepTcell, a fully synthetic peptide product, is reconstituted with Valneva’s depot-forming IC31™ TLR9 adjuvant and given by intramuscular injection.

The HepTcell Phase 1 study was a double-blinded, placebo-controlled, randomized, dose-escalation trial that enrolled 60 subjects with chronic hepatitis B who were HBeAg negative and well-controlled on licensed antivirals. Forty patients received one of two dose levels of HepTcell, with and without Valneva’s IC31 adjuvant, while twenty control patients received either placebo or IC31 alone. All patients received 3 injections 28 days apart, and were followed for 6 months after the final dose.

All dose combinations showed excellent tolerability and met the primary endpoint of safety. In the two adjuvanted HepTcell arms, T cell responses against HBV markedly increased over baseline compared to placebo. Altimmune plans to advance the program into Phase 2 development.

StephenW

Altimmune宣布在奥地利维也纳举行的国际肝病大会上展示HepTcell第一阶段结果

马里兰州盖瑟斯堡，2019年1月29日（GLOBE NEWSWIRE） - 临床阶段免疫治疗公司Altimmune，Inc。（纳斯达克股票代码：ALT）今天宣布其最近完成的HepTcell 1期临床试验结果将于4月份公布2019年12月12日，由欧洲肝脏研究协会（EASL）主办的国际肝脏大会于2019年4月10日至14日在奥地利维也纳举行。

如前所述，该研究符合其安全性的主要终点，并显示HepT细胞治疗与HBV特异性细胞免疫应答增加有关。这些结果将由Mark Thursz，MB BS，MD，FRCP，伦敦帝国理工学院肝脏病学教授在会议上作为口头报告，名为乙型肝炎 - 药物开发。

“我很高兴在EASL肝脏大会上展示这些令人兴奋的HepTcell数据，”HepTcell第一阶段研究的首席研究员Thursz教授说。 “HepTcell对HBV特异性细胞免疫反应的影响非常令人鼓舞，安全性非常好。”

乙型肝炎病毒（HBV）已在全球范围内感染了超过20亿人。感染HBV的大多数成人通过HBV特异性CD4 +和CD8 + T细胞实现自发清除;然而，全世界有超过2.57亿人，其中200万患者在美国，仍然受到慢性感染。由于肝硬化，肝功能衰竭和肝细胞癌等并发症，HBV仍然是全球死亡的主要原因。慢性感染患者在抗HBV T细胞反应的量级和质量方面存在严重缺陷，并且打破这种免疫耐受性是所有新型HBV治疗策略的关键目标。

Altimmune的HepTcell是一种特异性HBV免疫治疗药物，旨在驱动所有种族背景患者的所有HBV基因型的CD4 +和CD8 + T细胞反应。 HepTcell将免疫系统集中在HBV蛋白质组的离散高度保守区域。我们相信我们的方法允许HepTcell激活较少耐受的T细胞，从而导致更高的活性并降低由于病毒突变导致的免疫逃逸的可能性。 HepTcell是一种完全合成的肽产品，用Valneva的储库形成IC31™TLR9佐剂重建，并通过肌内注射给予。

HepTcell 1期研究是一项双盲，安慰剂对照，随机，剂量递增试验，招募了60名慢性乙型肝炎患者，这些患者HBeAg阴性并且在许可的抗病毒药物上得到良好控制。 40名患者接受两种剂量水平的HepT细胞中的一种，有和没有Valneva的IC31佐剂，而20名对照患者接受安慰剂或单独的IC31。所有患者间隔28天接受3次注射，并在最终剂量后跟踪6个月。

所有剂量组合均显示出优异的耐受性并且符合安全性的主要终点。在两个佐剂化的HepT细胞臂中，与安慰剂相比，针对HBV的T细胞应答显着高于基线。 Altimmune计划将该计划推进到第二阶段的发展

左罗

除安全性外，怎么不见针对HBV的药效试验数据呢？